Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Concurrent Pemetrexed, Cisplatin and Radiotherapy in Local Advanced Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00846443
Recruitment Status : Unknown
Verified February 2009 by Fudan University.
Recruitment status was:  Recruiting
First Posted : February 18, 2009
Last Update Posted : February 18, 2009
Sponsor:
Information provided by:
Fudan University

Tracking Information
First Submitted Date  ICMJE February 17, 2009
First Posted Date  ICMJE February 18, 2009
Last Update Posted Date February 18, 2009
Study Start Date  ICMJE January 2009
Estimated Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
Dose-limiting toxicities per protocol [ Time Frame: every 3 months from the end of treatment to 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Concurrent Pemetrexed, Cisplatin and Radiotherapy in Local Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase I Study of Concurrent Pemetrexed, Cisplatin and Radiotherapy in Local Advanced Non-Small Cell Lung Cancer.
Brief Summary The purpose of this study is to determine the recommended dose of pemetrexed and the maximum tolerated dose of radiotherapy when using concurrent pemetrexed/cisplatin/radiotherapy in the patients with local advanced non-small cell lung cancer.
Detailed Description This study was conducted to explore the feasibility of concurrent chemoradiation therapy with pemetrexed, cisplatin and radiotherapy in unresectable local advanced non-small cell lung cancer. We will perform the dose escalation of pemetrexed to determine if full dose (500mg/m2) of pemetrexed could be administrated concurrently with cisplatin and conventional dose radiotherapy (66Gy) firstly. Secondly, radiation dose will be escalated to determine the maximum tolerated dose (MTD) of radiotherapy when administered concurrently with full dose pemetrexed and cisplatin.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Local Advanced Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy
    pemetrexed:400 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions
  • Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy
    pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions
  • Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy
    pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:70 Gy in 35 fractions
  • Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy
    pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:74 Gy in 37 fractions
Study Arms  ICMJE
  • Experimental: 1
    pemetrexed:400 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions
    Intervention: Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy
  • Experimental: 2
    pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions
    Intervention: Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy
  • Experimental: 3
    pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:70 Gy in 35 fractions
    Intervention: Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy
  • Experimental: 4
    pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:74 Gy in 37 fractions
    Intervention: Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 17, 2009)
12
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≧18 years.
  • Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  • Patients with histologically or cytological-proven non-small cell lung cancer.
  • Stage IIIA or IIIB, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
  • Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
  • Weight loss ≦ 5% in the previous six months.
  • Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
  • Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
  • Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

  • Undifferentiated small cell carcinoma, any stage.
  • Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
  • Stage IV.
  • Age <18 years.
  • Performance status ≧2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  • Previous chemotherapy or previous biologic response modifiers for current lung cancer.
  • Patient has previously had thoracic radiation therapy.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
  • Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
  • History of significant neurological or mental disorder, including seizures or dementia.
  • Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed. If a patient is taking an NSAID (Cox-2 inhibitors included) or salicylate with a long half-life (e.g. naproxen, piroxicam, diflusinal, nabumetone, rofecoxib, or celecoxib) it should not be taken 5 days before, the day of, and 2 days after the dose of pemetrexed.
  • Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
  • Pregnant or lactating females.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00846443
Other Study ID Numbers  ICMJE NSCLC2009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiaolong Fu, Cancer Hospital, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fudan University
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP